Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring an Associate Director, Data Standards to join our Biometrics team! In this role, you produce CDISC deliverables including SDTM, ADaM, and submission packages along with helping to develop strategy for data standards at Rho. In addition, you will provide oversight and management of Statistical Programmers with a data standards focus and activities within Rho’s Regulatory Strategy and Biometrics Team.

Our Biometrics Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the team.

This role can be remote in Poland.

• Develops and implements data standards strategy, policies, and procedures for Rho, ensuring alignment with CDISC standards, sponsor expectations, and regulatory guidelines.
• Provides line management for Statistical Programmers with a data standards focus. Meet at least monthly with staff to provide mentorship and coaching, discuss professional development, and opportunities to increase knowledge and skill set.
• Ensure staff meet timelines, provide high-quality deliverables, comply with contractual project requirements within budget, and follow SOPs.
• Collaborates with the Statistical Programming and Data Management teams to ensure consistent and efficient data collection, transformation, and analysis across Rho's projects.
• Collaborates with other internal functional areas to establish and maintain Standard Operating Procedures (SOPs) and guidelines, promoting standardized and consistent processes to maximize efficiencies.
• Offers expertise in review and development of data standards deliverables, such as case report forms, SDTM and ADaM specifications, define.xml files, reviewer’s guides, and study data standardization plans.
• Evaluate CDISC and legacy data packages for regulatory submission readiness. Remediate identified gaps to ensure successful submission.
• Ensures data standards compliance and quality through regular audits, reviews, and validations.
• Identifies and resolves data standards issues and escalates them as appropriate.
• Stays abreast of the latest developments and trends in data standards and clinical research and provides recommendations for improvement and innovation.
• Acts as the external facing primary data standards lead in communications with sponsors, potential sponsors, and vendors.
• Supports business development activities by contributing to proposals, budgets, and presentations related to data standards services.
• Represents Data Standards at internal and external meetings and conferences.
• Effectively manages changes to study resources due to protocol amendments and changes to overall clinical development programs.
• Supports the assignment of staff to projects in a manner which keeps them at their utilization goal and which matches them to projects appropriate for their skills, training, experience, and development.
• Meets with manager regularly to evaluate and develop solutions for project resourcing, quality considerations, timelines, budgets, processes, and training needs.

• BA/BS in computer science, statistics, or related field.
• A minimum of 8 years supporting CDISC deliverables within the CRO/Pharmaceutical industry; preference for experience within a statistical programming group, which includes a minimum of 2 years of experience training, mentoring, and providing feedback for peers and junior level programmers with proven leadership abilities.
• Understanding of clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Extensive experience with SDTM model, including transforming raw data files while adhering to CDISC standards as well as SDTM submission deliverables.
• Understanding of ADaM model and experience with specifications, conformance of ADaM CDISC and ADaM submission deliverables.
• Experience providing technical guidance to programming staff and vendors around standards, practices, and specifications and strong data analysis skills.
• Ability to identify challenges, inefficiencies or downstream impacts as well as potential solutions and engagement of appropriate stakeholders to minimize risk and maximize quality for all points of involvement in study planning and execution.
• Ability to provide both support and leadership to multiple projects across a variety of therapeutic areas with no oversight.
• Must be able to establish and maintain effective working relationships with other directors in the statistical programming, biostatistics, and data management departments as well as project team members in other functional areas in a highly collaborative environment.
• Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company.
• Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
• Experience interacting with sponsors is required.

Please submit your CV in English. Thank you!